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Assignment within the Production Process – B7 (Biologics). Strong need on Downstream Processing (DSP) production deviations, with a significant backlog to manage. New role within the organization: the consultant will report directly to the Hiring Manager or the DSP Production Manager. Mission is 100% focused on deviation management.
Job Responsibility
End-to-end management of DSP production deviations, from opening to closure
Field investigation: Regular presence in production areas, conducting interviews with technicians and operators, understanding and challenging equipment functioning and process steps
Writing of deviations in the Quality System (minor, major, clustered deviations)
Close collaboration with cross-functional teams: Production teams, QA / QA Validation, MSAT / QAMSAT, Maintenance / Technical Services
Participation in root cause analysis (RCA) and definition of corrective and preventive actions (CAPA)
Defense and explanation of technical analyses in front of QA and other stakeholders
Requirements
4–6 years of experience in a similar role in the pharmaceutical / biologics industry
Proven experience in writing and managing production deviations (end-to-end)
What we offer
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe